Events

Retiro De Equipo (Recall) de Infinity Acute Care System Monitoring - M540

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Draegerwerk AG & Co KGaA.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    22734
  • Fecha de inicio del evento
    2018-03-21
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Causa
    The manufacturer has determined that when the infinity m540 patient monitor with software versions vg4.1 and below is used in combination with the infinity mcable mainstream c02 (m11.1) revision 16 sensor, the infinity m540 patient monitor will reboot if the sensor enters a reduced accuracy mode. should the infinity m540 patient monitor reboot 3 times within a 10 minute period or less, the infinity m540 patient monitor will go into a fail-state, resulting in a resetting to factory defaults, losing patient settings and stored patient data.
  • Acción
    Software to be upgraded

Device

Infinity Acute Care System Monitoring - M540

Manufacturer

Draegerwerk AG & Co KGaA